Van Vollenhoven R.F.,Karolinska University Hospital |
Geborek P.,Lund University |
Forslind K.,Lund University |
Forslind K.,Helsingborg Hospital |
And 5 more authors.
The Lancet | Year: 2012
Background: Analysis of the Swedish Farmacotherapy (Swefot) trial at 12 months showed that the addition of an antitumour-necrosis-factor agent gave an improved clinical outcome compared with the addition of conventional diseasemodifying antirheumatic drugs in patients with methotrexate-refractory early rheumatoid arthritis. Here we report the 2 year follow-up assessment. Methods: In this randomised, non-blinded, parallel-group trial, we enrolled adult patients older than 18 years with rheumatoid arthritis and a symptom duration of less than 1 year from 15 rheumatology units in Sweden between December, 2002 and December, 2006. All patients were started on methotrexate. After 3-4 months, those who failed treatment were randomly assigned (1:1) to group A (conventional treatment; additional sulfasalazine and hydroxychloroquine) or group B (biological treatment; additional infliximab). Randomisation was done with a computer-generated sequence. We analysed clinical outcomes at months 18 and 24 by the response criteria of the American College of Rheumatology and the European League Against Rheumatism, and radiographs of patients' hands and feet at months 12 and 24 using the Van der Heijde modification of the Sharp score. Analysis was by intention to treat. This trial is registered with www.ClinicalTrials.gov, number NCT00764725. Findings: Of 493 screened individuals, we enrolled 487, of whom 258 were randomly allocated to treatment. The proportion of patients in group B who received a EULAR-defined good response was non-significantly greater than it was in group A at 18 months (49 of 128 [38%] vs 38 of 130 [29%]) and at 24 months (49 of 128 [38%] vs 40 of 130 [31%]; p=0·204). After 24 months, radiological disease progression was greater in patients in group A than it was in those in group B (mean 7·23 [SD 12·72] vs 4·00 [10·0]; p=0·009). We recorded three serious adverse events: an extended generalised illness in group A, an extended febrile episode in group B, and a generalised illness in group B. Interpretation: Additional biological treatment is a valid option for patients who fail initial methotrexate treatment. However, improved clinical outcomes after 12 months and better radiographical results after 24 months should be weighed against the absence of a convincing clinical difference at 24 months and substantially higher costs. Therefore, for many patients who fail initial methotrexate treatment, add-on treatment with disease-modifying antirheumatic drugs is an appropriate treatment option. Funding: Swedish Rheumatism Association, Stockholm County, and Schering-Plough/Merck Sharp and Dohme.
Akesson O.,Helsingborg Hospital |
Syk I.,Skåne University Hospital |
Lindmark G.,Helsingborg Hospital |
Buchwald P.,Helsingborg Hospital
International Journal of Colorectal Disease | Year: 2012
Aim: A defunctioning loop ileostomy in low anterior resection reduces the incidence and morbidity of an anastomotic leakage, but complications related to the stoma may occur. We explored stoma-associated complications during the stoma period and after stoma reversal. Methods: A retrospective analysis of rectal cancer patients operated with low anterior resection and a defunctioning loop ileostomy at Helsingborg Hospital and Malmö University Hospital from January 2007 to June 2009 was undertaken. Results: Ninety-two patients were included, of whom 82 (89 %) underwent stoma reversal. The median stoma period was 6.2 ± 3.2 months. Sixty-six percent of the patients suffered from minor or major stoma-associated morbidity. The complication rate was significantly related to the stoma time (p < 0.01). Twenty-nine percent (27/92) had at least one episode of dehydration, leading to readmittance in half of the cases. Elderly patients were more prone to develop dehydration. Dehydration most commonly occurred early in the postoperative period (mean, 5.8 weeks). The mean hospital stay for stoma reversal was 6.5 ± 4.0 days. Forty percent (33/82) had some complication associated with the reversal. Conclusion: This study indicates high morbidity associated with defunctioning loop ileostomy. Our data suggest that the stoma time should be limited to reduce complications. Monitoring and early stoma reversal should be considered in elderly patients. Furthermore, stoma reversal is not uneventful, and more studies are needed to address how to minimize complications. © 2012 Springer-Verlag.
Rung L.,Helsingborg Hospital |
Lovestam-Adrian M.,Skåne University Hospital
Clinical Ophthalmology | Year: 2013
Background: The purpose of this study was to evaluate the visual outcome and self-reported vision-targeted health status in patients treated with intravitreal ranibizumab for wet age-related macular degeneration (AMD). Methods: A total of 51 eyes from 50 patients aged 76 ± 7 years, with wet AMD not previously treated, were included in this prospective study. Best corrected visual acuity was examined using Early Treatment Diabetic Research Study charts and near vision reading. All patients underwent an ophthalmological examination, including fluorescein and indocyanine green angiography (occult cases) and optical coherence tomography. The Visual Function Questionnaire test was completed before and 37 ± 7 months after the start of intravitreal injections. Results: The patients received a mean number of 7.8 ± 5.0 (range 2-22) injections. One month after the third intravitreal injection, significant improvement was seen in both visual acuity (53 ± 14 to 61 ± 14 letter, P = 0.001) and near vision (17 ± 9 to 11 ± 8 points, P = 0.001). During follow-up, mean visual acuity decreased from 53 ± 14 to 44 ± 24 letters (P = 0.011), and near vision decreased from 17 ± 9 to 20 ± 11 points (P = 0.048). Despite visual impairment, the quality of life test revealed no significant decrease in mental health (P = 0.529) or ability to read a newspaper (P = 0.21), but a decrease in distance activities (reading street signs, steps, going to the theater) from 57 ± 27 to 46 ± 31 points (P = 0.007) was documented. Conclusion: Decreased visual acuity was related to a decrease in self-reported visual function for distance activities, while mental health items, such as worrying, were not influenced. © 2013 Rung and Lövestam-Adrian, publisher and licensee Dove Medical Press Ltd.
Lundstrom K.-J.,Ostersunds Hospital |
Sandblom G.,Karolinska Institutet |
Smedberg S.,Helsingborg Hospital |
Nordin P.,Ostersunds Hospital |
Nordin P.,Umeå University
Annals of Surgery | Year: 2012
Objective: This study aims to analyze and identify risk factors for postoperative complications and analyze the relative risk of reoperation for recurrence for respective complication. Background: The outcome of groin hernia surgery is evaluated mostly by comparing recurrence rates and long-term pain. The aim of this observational population-based registry study was to identify risk factors for postoperative complications and analyze the relative risk of reoperation for recurrence for respective complication. Methods: Using data from the nationwide Swedish Hernia Register between 1998 and 2009, 150,514 herniorrhaphies were analyzed with respect to postoperative complications occurring within 30 days of surgery. Results: Risk factors significantly affecting the rate of postoperative complications were laparoscopic repair (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.24-1.47) and open preperitoneal techniques (OR: 1.31, 95% CI: 1.15-1.49), with open anterior mesh as reference category. Other significant risk factors were general (OR: 1.30, 95% CI: 1.23-1.37) and regional anesthesia (OR: 1.53, 95% CI: 1.43-1.63), with local anesthesia as reference category, emergency procedures (OR: 1.53, 95% CI: 1.43-1.63); recurrent hernia repair (OR: 1.39, 95% CI: 1.27-1.52); femoral hernia (OR: 1.30, 95% CI: 1.14-1.48); aged older than 65 years (OR: 1.26, 95% CI: 1.21-1.31); and duration of surgery exceeding 50 minutes (OR: 1.27, 95% CI: 1.22-1.33). Conclusions: Open anterior approach and surgery under local anesthesia are associated with less risk of postoperative complications. © 2012 Lippincott Williams & Wilkins.
Londahl M.,Lund University |
Katzman P.,Lund University |
Nilsson A.,Angelholm Hospital |
Hammarlund C.,Helsingborg Hospital
Diabetes Care | Year: 2010
OBJECTIVE - Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. The aim of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) in the management of chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS - The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers (HODFU) study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air. Treatments were given in a multi-place hyperbaric chamber for 85-min daily (session duration 95 min), five days a week for eight weeks (40 treatment sessions). The study was performed in an ambulatory setting. RESULTS - Ninety-four patients with Wagner grade 2, 3, or 4 ulcers, which had been present for >3 months, were studied. In the intention-to-treat analysis, complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up: 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P=0.03). In a sub-analysis of those patients completing >35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group (P = 0.009). The frequency of adverse events was low. CONCLUSIONS - The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes. © 2010 by the American Diabetes Association.
Jorgren F.,Helsingborg Hospital |
Johansson R.,Umeå University |
Damber L.,Umeå University |
Lindmark G.,Helsingborg Hospital
Acta Oncologica | Year: 2013
Background. Founded in 1995, the Swedish Rectal Cancer Registry (SRCR) is frequently used for rectal cancer research. However, the validity of the registry has not been extensively studied. This study aims to validate a large amount of registry data to assess SRCR quality. Material and methods. The study comprises 906 patients treated with major abdominal surgery registered in the SRCR between 1995 and 1997. SRCR data for 14 variables were scrutinized for validity against the medical records. Kappa's and Kendall's correlation coefficients for agreement between SRCR data and medical records data were calculated for 13 variables. Results. For 11 variables, concerning the tumor, neoadjuvant therapy, the surgical procedure, local radicality and TNM stage, data were missing in 5% or less of the registrations; for the remaining three variables, anastomotic leakage, local and distant recurrence, data were missing in 13-38%. For the variables surgery performed or not and type of surgical procedure, no data were missing. Erroneous registrations were found in less than 10% of all variables; for the variables preoperative chemotherapy and surgery performed or not, all registrations were correct. For the variables concerning neoadjuvant therapy, local radicality according to the surgeon as well as the pathologist and distant metastasis, the false-positive or -negative registrations were equally distributed, and for the variables rectal washout, rectal perforation, anastomotic leakage and local recurrence there was a discrepancy in distribution. The correlation coefficient for 12 variables ranged from 0.82 to 1.00, and was 0.78 for the remaining variable. Conclusion. The validity of the SRCR was good for the initial three registry years. Thus, research based on SRCR data is reliable from the beginning of the registry's use. © 2013 Informa Healthcare.
Kvist L.J.,Lund University |
Kvist L.J.,Helsingborg Hospital
International Breastfeeding Journal | Year: 2013
Background: The reported incidence of lactational mastitis varies greatly; the single highest reported incidence in the scientific literature is 33%. The purpose of this study was to collect data regarding incidence and experiences of lactational mastitis from women attending a meeting of lactation specialists and to compare findings in a similar population reported in 1990 by Riordan and Nichols.Methods: A retrospective questionnaire study was carried out with a group of Danish lactation specialists in 2011. The questionnaire was constructed to replicate that used in 1990 and included questions about occurrence of mastitis, the infant's age, breast segments afflicted, examination by a physician, use of antibiotics and possible causes of the illness. Results: As in the earlier research, respondents in this study reported a 33% occurrence of lactational mastitis. This cannot however, be considered as the incidence of mastitis. In order to state the incidence it is necessary to impose a time limit for the collection of data and to know the size of the population at risk. Incomplete emptying of the breast was the factor most frequently cited as the cause of mastitis.Conclusions: Researchers must strive to be as exact as possible when reporting definitions and incidences of mastitis and should attempt to identify the true population at risk - in this case, all women who were breastfeeding in the uptake area under study, during a specified time limit. Well-designed studies in different global locations are needed before any conclusions can been drawn about the range of incidences of mastitis. © 2013 Kvist; licensee BioMed Central Ltd.
Nielsen N.,Lund University |
Nielsen N.,Helsingborg Hospital |
Friberg H.,Lund University
Current Opinion in Critical Care | Year: 2015
Purpose of review Temperature management for patients comatose after cardiac arrest has been an integral component of postcardiac arrest care for the last decade. In this review, we present recent findings and discuss implications for future trials. Recent findings The two largest trials on temperature management after cardiac arrest were recently presented. The first investigated prehospital induction of hypothermia using ice-cold intravenous saline in 1364 patients. The intervention gave a significant reduction in time from return of circulation to start of hypothermia and lower body temperature on admission to hospital. There was no difference in survival or neurological function between the study groups, but there were indications of possible harm in the group that received saline. The second trial investigated two actively controlled temperatures provided in intensive care units, randomizing 950 unconscious patients suffering out-of-hospital cardiac arrest of a presumed cardiac cause to targeted temperature management at 33 and 36°C. There was no difference in survival until end of trial or neurological function at 180 days. Summary Prehospital hypothermia induced by cold crystalloid infusion does not benefit cardiac arrest patients. For patients treated in an intensive care unit targeting a temperature of 36°C provides similar results as targeting 33°C. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Sunden F.,Helsingborg Hospital |
Wullt B.,Lund University
International Journal of Urology | Year: 2016
Objectives: To study urinary interleukin-6, interleukin-8 and pyuria during episodes of asymptomatic bacteriuria and symptomatic urinary tract infection in the institutionalized elderly, and to investigate the role of interleukin-6 as a biomarker for differential diagnosis. Methods: Levels of interleukin-6, interleukin-8 and pyuria were assessed in 35 older adults with asymptomatic bacteriuria and symptomatic urinary tract infection to define possible diagnostic thresholds. In a two-phase intervention study, the antibiotic treatment for urinary tract infection before and after introduction of urinary interleukin-6 as a biomarker was then assessed. Results: Asymptomatic bacteriuria patients had no or low levels of interleukin-6, and low levels of interleukin-8 and pyuria. Women had lower interleukin-6 and interleukin-8 than men (P = 0.05). Interleukin-6 was the only marker showing significant increases during urinary tract infection episodes in patients with both asymptomatic bacteriuria and urinary tract infection, in pooled (P = 0.042) and in paired intra-individual (P = 0.017) comparisons. In the intervention study lectures, the increased use of urine cultures and the introduction of interleukin-6 as a biomarker reduced antibiotic treatments by 20%. Antibiotic-treated urinary tract infection episodes had increased interleukin-6 as compared with urinary tract infection episodes not treated (P = 0.02), and as compared with asymptomatic bacteriuria patients (P < 0.0001). The sensitivity and specificity of interleukin-6 (cut-off 25 pg/mL) differentiating asymptomatic bacteriuria from urinary tract infection was 57% and 80%, respectively. Conclusions: Urinary interleukin-6 shows promise as a biomarker to detect the transition from asymptomatic bacteriuria to symptomatic urinary tract infection in older adults. Further larger studies with robust methodology are warranted to determine whether development for near to patient testing would be worthwhile. © 2016 The Japanese Urological Association.
Rydenfalt C.,Lund University |
Johansson G.,Lund University |
Odenrick P.,Lund University |
Akerman K.,Helsingborg Hospital |
Larsson P.A.,Helsingborg Hospital
International Journal for Quality in Health Care | Year: 2013
Background: Previous research suggests that the World Health Organization Surgical Safety Checklist time-out reduces communication failures and medical complications and supports development of better safety attitudes. Previous research also indicates that different values can affect the implementation of interventions. Objective: To investigate the actual usage of the checklist in practice and to catalogue deviations for the purpose of identifying improvements. Design: Twenty-four surgical procedures were video recorded. The time-out was analysed quantitatively assessing compliance with a predefined observational protocol based on the checklist and qualitatively to describe reasons for non-compliance. Setting: The operating unit of a Swedish county hospital. Main outcome measures: Compliance with checklist items and the participation of different personnel groups. Activities were conducted during the time-out. Results: Highest compliance was associated with patient ID, type of procedure and antibiotics; the worst with site of incision, theatre nurse team reviews and imaging information. Team member introductions occurred in half of the operations. Surgeons and the anaesthesia team dominated the time-out. Conclusion: The checklist is not always applied as intended. The components that facilitate communication are often neglected. The time-out does not appear to be conducted as a team effort. It is plausible that the personnel's conception of risk and the perceived importance of different checklist items are factors that influence checklist usage. To improve compliance and involve the whole team, the concept of risk and the perceived relevance of checklist items for all team members should be addressed. © The Author 2013.